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Last Updated: November 26, 2020

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CLINICAL TRIALS PROFILE FOR HUMALOG

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505(b)(2) Clinical Trials for Humalog

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT04161976 A Study of LY900027 Given by Insulin Pump to Participants With Type 1 Diabetes Mellitus Not yet recruiting Eli Lilly and Company Phase 1 2019-12-16 The main purpose of this study is to learn more about a new formulation of insulin lispro when given by an insulin pump to participants with type 1 diabetes mellitus. The study will investigate how the body processes the drug and how the drug affects the body. Information about side effects will be collected. The study will last from six to 12 weeks for each participant.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Humalog

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00046501 Compare Blood Sugar Level Between Lantus in the Morning and Other Insulins in Type 1 Diabetes Adolescents Completed Sanofi Phase 3 2002-11-01 The purpose of the study is to compare the effect in blood sugar control between Lantus and twice daily intermediate acting insulins (NPH or Lente) when used as the basal insulin in a multiple daily injection setting with fast acting insulin (Lispro)
NCT00071448 Insulin Aspart vs. Insulin Lispro vs. Regular Insulin in Paediatric Population Completed Novo Nordisk A/S Phase 3 2002-06-01 This trial is conducted in the United States of America (USA). The aim of this trial is to to determine whether insulin aspart can be used effectively and safely in paediatric patients.
NCT00097071 Safety and Efficacy of NovoLog vs. Humalog in Insulin Pumps in Children and Adolescents Completed Novo Nordisk A/S Phase 3 2004-10-01 This trial is conducted in the United States of America (USA). It is demonstrated that intensive insulin therapy resulting in good glycaemic control can reduce or delay the incidence of complications secondary to Type 1 Diabetes. Insulin Aspart (NovoLog®) is an ideal insulin to use in an intensive insulin regimen using continuous subcutaneous insulin injection (CSII) therapy in the pediatric and adolescent age population. This trial compares the safety and efficacy of Insulin Aspart (NovoLog®) and Insulin Lispro (Humalog®) delivered by CSII in children and adolescents with type 1 diabetes.
NCT00115570 Comparison of the Ability of Glulisine With Lispro to Control Type 1 Diabetes Mellitus in Children and Adolescents Completed Sanofi Phase 3 2005-04-01 The purpose of this study is to determine if insulin glulisine (Apidra) is as safe and effective a rapid acting insulin as insulin lispro (Humalog) in children and adolescents with type 1 diabetes mellitus.
NCT00191282 Hyperglycemia and Cardiovascular Outcomes With Type 2 Diabetes Completed Eli Lilly and Company Phase 4 2002-10-01 The primary objective was to demonstrate a difference between two insulin strategies, one targeting postprandial (PP) hyperglycemia and the other targeting fasting and interprandial hyperglycemia, on time until the first combined adjudicated cardiovascular (CV) event (primary outcome defined as CV death, nonfatal myocardial infarction [MI], nonfatal stroke, coronary revascularization, or hospitalized acute coronary syndrome).
NCT00191581 Local Registration Trial in China Humalog Mix 50 Completed Eli Lilly and Company Phase 3 2005-03-01 The primary objective of this study is to compare the 2-hour PPBG excursion following a standard test meal in insulin-requiring diabetic patients treated twice daily with human insulin mix 50/50, versus the 2-hour PPBG excursion in patients treated twice daily with insulin lispro mix 50/50.
NCT00206401 Lantus in the Treatment of Type 1 Diabetes Children Completed Baylor College of Medicine Phase 4 2004-11-01 In this study, we plan to examine the difference in effect on blood glucose control in patients who will be on either conventional insulin therapy (i.e. using NPH and Humalog twice daily, injected separately) or on intensive insulin management (IIM-several shots of short acting and Glargine insulin). Those on IIM will be mixing the insulin Glargine with the short-acting insulin analog prior to injecting. The Hemoglobin A1c (HbA1c) results will be used to monitor blood glucose control over a 6 month period. Twice during the course of the study, a continuous glucose monitoring system (CGMS-a device the size of a pager that records blood sugar readings every 5 minutes) will be used to record all the changes in the blood glucose levels occurring over a 72-hour period.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Humalog

Condition Name

Condition Name for Humalog
Intervention Trials
Type 1 Diabetes Mellitus 24
Diabetes Mellitus, Type 1 22
Diabetes Mellitus, Type 2 20
Type 2 Diabetes Mellitus 14
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Condition MeSH

Condition MeSH for Humalog
Intervention Trials
Diabetes Mellitus 108
Diabetes Mellitus, Type 1 65
Diabetes Mellitus, Type 2 36
Hyperglycemia 14
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Clinical Trial Locations for Humalog

Trials by Country

Trials by Country for Humalog
Location Trials
United States 489
Germany 43
China 35
Canada 24
Australia 22
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Trials by US State

Trials by US State for Humalog
Location Trials
California 36
Texas 26
Florida 26
Georgia 25
Colorado 20
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Clinical Trial Progress for Humalog

Clinical Trial Phase

Clinical Trial Phase for Humalog
Clinical Trial Phase Trials
Phase 4 31
Phase 3 28
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Humalog
Clinical Trial Phase Trials
Completed 85
Not yet recruiting 19
Recruiting 17
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Clinical Trial Sponsors for Humalog

Sponsor Name

Sponsor Name for Humalog
Sponsor Trials
Eli Lilly and Company 46
Adocia 17
Sanofi 13
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Sponsor Type

Sponsor Type for Humalog
Sponsor Trials
Industry 122
Other 45
NIH 1
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